Treatment of Alcohol Dependence and Comorbid Bipolar Disorder

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 4

Conditions: Psychosis; Bipolar Disorder; Depression; Mania; Alcohol Dependence

Treatments: Drug: Placebo; Drug: Lamotrigine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01015586

K23AA017666 (U.S. NIH Grant/Contract)

HR#19550

Details and patient eligibility

About

The study will determine if individuals with co-occurring bipolar disorder and alcohol dependence report reduced alcohol consumption, improvement in mood symptoms, and cognitive performance if treated with lamotrigine plus their usual mood stabilizing medications relative to subjects treated with placebo plus usual mood stabilizing medications over a 16 week period.

Enrollment: 43 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-65

• Meet DSM-IV-TR criteria for current alcohol dependence with active alcohol use in the past 30 days

• Meet DSM-IV-TR criteria for bipolar I or bipolar II disorder

• Have average alcohol consumption of at least 35 drinks/week for men, 28 drinks/week for women in the last 4 weeks of active drinking prior to enrollment.

• Able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of the assessment instruments.

• Must consent to random assignment and be willing to commit to medication treatment and follow-up assessments.

• Currently under the care of a psychiatrist.

• Must consent to sign a release of information allowing investigators to communicate with his/her psychiatrist to verify treatment history and facilitate care should treatment-emergent psychiatric symptoms develop during the trial.

• Currently taking a therapeutic dosage of one or more mood stabilizing medications as defined by one or more of the following:

  • Lithium level of 0.6 - 1.2 mEq/L
  • Prescribed daily use of first generation antipsychotic agents including chlorpromazine, fluphenazine, or haloperidol or their injectible depot (decanoate) equivalents at a dose adequate to maintain clinical stability as documented by the subject's outpatient psychiatric provider c) Prescribed daily use of second generation antipsychotic agents including olanzapine, risperidone, paliperidone, quetiapine, aripiprazole, or ziprasidone or their injectible depot equivalent at a dose adequate to maintain clinical stability as documented by the subject's outpatient psychiatric provider

• Stable psychiatric symptoms as defined by no changes to psychotropic drug regimen for 30 days

• Must agree to identify collateral individuals for contact to facilitate follow-up appointments

Exclusion criteria

• A primary psychiatric diagnosis other than bipolar disorder
• Any uncontrolled neurologic condition (e.g. epilepsy) that could confound the results of the study
• Any history of Stevens-Johnson syndrome or other severe rash requiring hospitalization
• Any history of head injury with loss of consciousness greater than 30 minutes
• Any history of learning disability, alcoholic dementia, or electroconvulsive therapy in the past 3 months
• Any uncontrolled medical condition that may adversely affect the conduct of the trial or jeopardize the safety of the subject
• Plasma levels of liver transaminases (AST, ALT) greater than 3 times the normal range
• Concomitant use of valproic acid
• Concomitant use of carbamazepine, oxcarbazepine, phenytoin, primidone, or phenobarbital
• Concomitant use of disulfiram, naltrexone, acamprosate, or topiramate
• Concomitant use of benzodiazepines or any other medications not allowed per the protocol
• Women of childbearing potential who are pregnant, lactating, or refuse adequate forms of contraception
• Current suicidal or homicidal risk
• Baseline scores of more than 35 on the Montgomery-Asberg Depression Rating Scale or more than 16 on the Young Mania Rating Scale

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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43 participants in 2 patient groups, including a placebo group

Lamotrigine

Experimental group

Description:

Add-on lamotrigine plus pre-existing mood stabilizing medication regimen. Active fixed-dose drug titration from 25-200 mg/day over first six weeks, 200 mg/day fixed-dose maintenance for second six weeks

Treatment:

Drug: Lamotrigine

Placebo

Placebo Comparator group

Description:

Add-on placebo plus pre-existing mood stabilization regimen for 12 weeks

Treatment:

Drug: Placebo